Analysis of Peripheral Blood Lymphocytes in Patients With Juvenile Idiopathic Arthritis With Respect to Disease Subtypes and Therapy

May 9, 2024 updated by: Hager Ibrahim Abdelaal, Sohag University

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children.

JIA is an umbrella term defining several forms of chronic arthritis with an onset before the age of 16 years, persisting for more than six weeks and with an unknown cause.

Based on the current International League of Associations in Rheumatology classification criteria (ILAR 2003) , different subtypes of JIA can be distinguished, essentially by a very limited set of clinical features (number of affected joints in the first six months of disease, extra-articular manifestations like fever or features of psoriasis) and serology (presence or absence of rheumatoid factor, RF). The most frequently diagnosed JIA subtypes are oligoarticular JIA (oJIA), polyarticular JIA (pJIA), and systemic JIA (sJIA). Less frequently occurring subtypes are enthesitis-related JIA, psoriatic arthritis, and undefined arthritis.

The pathophysiology mechanisms associated to JIA development are related to an abnormal activation of immune system cells such as B cells, T cells, natural killer (NK) cells, dendritic cells (DCs), monocytes, neutrophils, plasma cells, and to the production and release of pro-inflammatory mediators that ultimately lead to cartilage and bone destruction and systemic manifestations.

JIA has been classically considered a T-cell driven autoimmune disease, except for sJIA subtype, in which innate immune cells have a central role in disease pathogenesis. However, the detection of autoantibodies reacting with different target antigens in JIA patients suggests a central role of B cells in JIA pathophysiology.

Therapeutic intervention of jia begins at diagnosis with non-steroidal anti-inflammatory drugs (NSAIDs) followed by disease-modifying anti-rheumatic drugs (DMARDs, most often methotrexate) and/or corticosteroid intra-articular injection.

NSAIDs obtain both analgesic and anti-inflammatory effects. Local corticosteroid joint injections are effective in synovitis and may be a first-line treatment for oligoarthritis alone or in addition to DMARDs. Systemic administration of high dose corticosteroids provides good short-term effect, especially in sJIA patients.

The American College of Rheumatology (ACR) recommends early use of DMARDs, specifically MTX, leflunomide and/or sulfasalazine.

MTX is considered to be the first choice DMARD for oligo- and pJIA when NSAIDs and intraarticular steroids are insufficient.

MTX is also considered to be effective in children with PsJIA, though the axial manifestations limits prescription of MTX and so TNF inhibitors are typically required in these cases.

Leflunomide may be used as an alternative DMARD for pJIA in cases of MTX intolerance.

Sulfasalazine is recommended for patients with moderate activity of ERA with active peripheral arthritis, but is inefficient in case of sacroiliitis.

The emergence of biologic treatments has changed the prognosis for many JIA patients, whose condition did not improve adequately on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs), mainly methotrexate, or experienced side effects because of them. TNF-α inhibitors, such as etanercept, adalimumab , infliximab are widely used in JIA. In fact, etanercept is one of the most frequently prescribed biologics for JIA in many countries, including the United Kingdom. (19) Other biologics include tocilizumab , anakinra and canakinumab , abatacept and rituximab . The efficacy of biologics varies depending on the disease subtype.

Most healthy children have episodes of mild infections during the first years of life. In most cases, these episodes are respiratory or gastrointestinal viral infections. Children with juvenile idiopathic arthritis (JIA) have an allegedly higher risk of infection compared with healthy children because of their underlying condition.

Treatments used in JIA include corticosteroids, disease-modifying antirheumatic drugs (DMARDs), and biologic agents, all of which can increase the frequency of common mild infections and the risk of severe and opportunistic infections.

Disease-modifying anti-rheumatic drugs (DMARDs) help manage JIA by reducing inflammation and preventing joint damage, slowing the progression of the disease.

These therapies work by suppressing the immune system, which can lead to infection, despite growing evidence regarding the efficacy and safety of these drugs for children with JIA, it is unclear whether these agents increase the risk of infections - or whether the risk is increased to all or to only specific infections.

Moreover, there is a proportional relationship between the severity of the disease and the intensity of the treatment administered, and this association might constitute a confounding factor when assessing susceptibility to infections.

Besides novel findings, there is still little data available regarding the alteration of immune cells which control infection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abdellah M Radwan, professor
  • Phone Number: 01092914019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

-1. Patient age is above 16 years old 2. Patients who classified JIA according to International League of Associations for Rheumatology ILAR criteria received DMARDS therapy and in inactive state of disease

Description

Inclusion Criteria:

  • 1. Patient age is above 16 years old 2. Patients who classified JIA according to International League of Associations for Rheumatology ILAR criteria received DMARDS therapy and in inactive state of disease

Exclusion Criteria:

  • 1. Patients with active JIA 2. Any patient with any autoimmune disease other than JIA 3. Acquired and congenital lymphopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
juvenile idiopathic arthritis

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children JIA is an umbrella term defining several forms of chronic arthritis with an onset before the age of 16 years, persisting for more than six weeks and with an unknown cause.

Based on the current International League of Associations in Rheumatology classification criteria (ILAR 2003) , different subtypes of JIA can be distinguished, essentially by a very limited set of clinical features (number of affected joints in the first six months of disease, extra-articular manifestations like fever or features of psoriasis) and serology (presence or absence of rheumatoid factor, RF). The most frequently diagnosed JIA subtypes are oligoarticular JIA (oJIA), polyarticular JIA (pJIA), and systemic JIA (sJIA). Less frequently occurring subtypes are enthesitis-related JIA, psoriatic arthritis, and undefined arthritis. complete blood count will be done for all patients
Diagnostic test: Complete blood count

Complete blood count will be done for all patients and then will search about CD4, CD8 T lymphocyte cells surface markers

  • CD56 Natural killer cells surface marker
  • CD19 Lymphocyte cells surface marker
control group
control
Diagnostic test: Complete blood count

Complete blood count will be done for all patients and then will search about CD4, CD8 T lymphocyte cells surface markers

  • CD56 Natural killer cells surface marker
  • CD19 Lymphocyte cells surface marker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymphopenia
Time Frame: 1 year
lymphopenia in JIA patients receiving MTX and biological therapy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-24-04-03MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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